Ex Parte Solomon

Patent Trial and Appeal Board

Feb 28, 2017

13664399 (P.T.A.B. Feb. 28, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/664,399 10/30/2012 Neil A. Solomon 7043.004 1017
32867 7590 03/02/2017
WTT T TAMn HARF
EXAMINER
McNeely, Hare & War, LLP
12 Roszel Road
MUKHOPADHYAY, BHASKAR
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rKlJNCJilUJN, JNJ U«.74U-()234 1793
NOTIFICATION DATE DELIVERY MODE
03/02/2017 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte NEIL A. SOLOMON
Appeal 2016-002523
Application 13/664,399
Technology Center 1700
Before JEFFREY T. SMITH, MICHAEL P. COLAIANNI, and
MERRELL C. CASHION, JR., Administrative Patent Judges.
CASHION, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
This is an appeal under 35 U.S.C. § 134 from a final rejection of
claims 34, 36-48 and 53—55. We have jurisdiction under 35 U.S.C. § 6.
We AFFIRM.
Appeal 2016-002523
Application 13/664,399
Claim 34 is illustrative of the subject matter on appeal and is
reproduced below:
34. A method of using a solid lactase composition in
particulate form to treat lactose intolerance upon ingestion of a
food article comprising lactose, the lactase composition
consisting of particles, wherein the particles consist of a lactase
in solid form and a protective material configured such that the
protective material stabilizes the lactase in the food article,
when the solid lactase composition is in the presence of the
food article, from the lactose in the food article prior to
ingestion and wherein the protective material dissolves in acidic
or basic environment to release the lactase with the food article
upon consumption of the food article such that the lactase and
the particles are in the presence of the food article during
release of the lactase from the particles for the lactase to
hydrolyze the lactose from the food article, the method
comprising applying the lactase composition in particulate form
to the food article or using the lactase composition in the course
of consuming the food article, wherein the particles have a size
of about 400 microns or below such that the particles are not
perceptible or barely perceptible on the human tongue such that
upon consuming the food article the composition in particulate
form is not perceptible or is barely perceptible on the human
tongue.
Appellant requests review of the Examiner’s rejection of claims 34,
36-48, and 53—55 under 35 U.S.C. § 103(a) as unpatentable over Cayle (US
3,718,739, issued February 27, 1973) and Santos (US 5,955,096, issued
September 21, 1999). App. Br. 3.
Appellant does not argue any claim separate from the other. See
Appeal Brief, generally. Accordingly, we select claim 34 as representative
of the subject matter before us on appeal. Claims 36-48, and 53—55 stand or
fall with claim 34.
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Application 13/664,399
OPINION
Prior Art Rejection
After review of the respective positions provided by Appellant and the
Examiner, we AFFIRM for the reasons presented by the Examiner. We add
the following for emphasis.
Claim 34 is directed to a method of applying the lactase composition
in particulate form to the food article where the particulate form consists of a
lactase in solid form and a protective material that stabilizes the lactase in
the food article and has a particle size of about 400 microns or below.
The Examiner found Cayle teaches a method of treating lactose
intolerance upon ingestion of a food article comprising lactose by applying a
lactase composition in particulate form to the food article. Final Act. 3;
Cayle col. 3,11. 55-61, col. 4,11. 22-31, 45-60, col. 6,11. 55-60. The
Examiner found Cayle discloses the particulate form preparation as a
powder and a granule that may comprise a protective enteric coating. Final
Act. 3; Cayle col. 3,11. 55-61, col. 4,11. 22-31, 45-60, col. 6,11. 55-60. The
Examiner found Cayle does not teach the sizes of the granules or powders.
Final Act. 4. The Examiner found Santos teaches microencapsulated lactase
as particles having a protective coating where the microencapsulated
particles have a particle size ranging from 0.1—10 micrometers. Final Act
4—5; Santos col. 9, col. 58, col. 13,11. 32—35, 44, col. 14,11. 59—67; col. 15,
11. 48—53. The Examiner determined it would have been obvious to one of
ordinary skill in the art to modify the granular dosage form of Cayle
consisting of lactase and a protective coating to have a particle size within
the claimed range in view of the teachings of Santos. Final Act. 5.
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Appeal 2016-002523
Application 13/664,399
Appellant argues Cayle provides no guidance for formulating particles
that consist only of lactase and a protective material because Cayle describes
mixing the lactase enzyme with conventional solid fillers or carriers,
diluents, lubricants, disintegrants and coloring and flavoring agents. App.
Br. 4—5; Cayle col. 3,11. 55—68, col. 4,11. 1—6. Appellant further argues
Cayle does not teach or suggest using any protective material in the powder
or granular lactase enzyme preparations. App. Br. 5.
We are unpersuaded by these arguments and agree with the
Examiner’s determination of obviousness. Ans. 6—7; Final Act 4—5. As
noted by the Examiner, Cayle discloses a lactase preparation in the form of
granules and suggest providing solid preparations with an enteric coating if
needed. Final Act. 6—7; Cayle col. 3,11. 55—61; col. 4,11. 27—31. Although
Cayle teaches a preference for mixing the lactase with other additives to
make a solid formulation (Cayle col. 3,1. 62—col. 4,1. 6), it is well settled
that a reference may be relied upon for all that it would have reasonably
suggested to one having ordinary skill in the art, including non-preferred
embodiments. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807
(Fed. Cir. 1989) (“all disclosures of the prior art, including unpreferred
embodiments, must be considered”) (quoting In re Lamberti, 545 F.2d 747,
750 (CCPA 1976)). Appellant has not directed us to any portion of Cayle
that detracts from Cayle’s broader disclosure suggesting the use of only
lactase in solid form as part of the granular preparation. Cayle col. 3,1. 62-
col. 4,1. 6. Moreover, Santos also discloses pre-existing microspheres for
drug delivery having a protective coating and discloses lactase among the
materials that can be incorporated into microspheres. Santos col. 13,11. 32—
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Appeal 2016-002523
Application 13/664,399
43; col. 15,11. 48—53. Thus, Appellant has not adequately distinguished the
claimed invention from the teachings of the cited art.
Appellant argues Santos requires inclusion of at least one oligomer
with the polymer for the microspheres to enhance the bioadhesive properties
of polymers used in drug delivery systems. App. Br. 6—7; Santos Abstract,
col. 3,11. 10-14, 54—66. That is, Appellant argues the closed language of the
claim excludes Santos’ oligomer component from the claimed protective
coating. App. Br. 9.
We find this argument unavailing for the reasons given by the
Examiner. Ans. 7—8. Moreover, the closed language of claim 34 only
requires that the particulate form consists of a lactase in solid form and a
protective material and does not restrict the protective coating to any
particular composition that excludes Santos’ oligomer component.
Ans. 7—8.
Appellant argues neither Cayle nor Santos describes a need to make a
composition non-perceptible or barely perceptible on the human tongue.
App. Br. 7-9.
We are also unpersuaded by this argument for the reasons presented
by the Examiner. Ans. 9. Moreover, Appellant associates the particle’s
property of non-perceptible or barely perceptible on the human tongue with
the particle size. Spec. 7. Claim 34 requires particle sizes of about 400
microns or below. The Examiner found Santos discloses microspheres
having particle sizes of 0.1 to 10 microns, which fall within the claimed
particle size range. Ans. 8—9; Final Act. 4; Santos, col. 14,1. 59—col. 15,1.
14. In view of this, Appellant has not adequately explained why the
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Application 13/664,399
microspheres of Santos having a diameter of 0.1—10 microns would not have
been non-perceptible or barely perceptible on the human tongue as claimed.
Appellant argues evidence in the Declaration by the inventor, Dr. Neil
Solomon, (Declaration)1 shows surprising and unexpected results when a
formulation according to the claims was administered to individuals with
lactose intolerance. App. Br. 10. According to Appellant, the results are
surprising and unexpected because one of skill in the art would not have
expected the lactase/protective coating composition to reduce the symptoms
of lactose intolerance to levels comparable to healthy individuals without
lactose intolerance and to do so without affecting the taste of the ice cream.
App. Br. 11; Decl. Tflf 4—8.
When evidence of secondary considerations is submitted, we begin
anew and evaluate the rebuttal evidence along with the evidence upon which
the conclusion of obviousness was based. In re Rinehart, 531 F.2d 1048,
1052 (CCPA 1976). The burden of establishing unexpected results rests on
the person who asserts them. Appellants may meet their burden by
establishing that the difference between the claimed invention and the
closest prior art was an unexpected difference. See In re Klosak, 455 F.2d
1077, 1080 (CCPA 1972). The unexpected results must be established by
factual evidence, and attorney statements are insufficient to establish
unexpected results. See In re Geisler, 116 F.3d 1465, 1470-71 (Fed. Cir.
1997). Further, a showing of unexpected results supported by factual
evidence must be reasonably commensurate in scope with the degree of
1 The Declaration under 37 C.F.R. § 1.132 by Dr. Neil Solomon was filed by
Appellant on November 1, 2013 in response to the Non-Final Action dated
May 1,2013.
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Application 13/664,399
protection sought by the claims on appeal. In re Grasselli, 713 F.2d 731,
743 (Fed. Cir. 1983); In re Clemens, 622 F.2d 1029, 1035 (CCPA 1980).
We agree with the Examiner that the evidence in the Declaration is
not commensurate in scope with the claims. Ans. 11—12. Moreover, the
showing in the Declaration is insufficient to establish unexpected results
because it lacks information as to the number of tests performed or the
dosages for the lactase used in the tests. That is, the showing does not
inform the skilled artisan as to the amount of lactase that results in reducing
the symptoms of lactose intolerance to levels comparable to healthy
individuals without lactose intolerance shown in Table 1. Deck 17. Thus,
one skilled in the art is unable to ascertain if this proffered showing, in fact,
demonstrates the unexpected results asserted by Appellant.
On this record, Appellant has not adequately shown, much less
explained, why the evidence relied upon would have been unexpected by
one of ordinary skill in the art or is reasonably commensurate in the scope
with the claims. See, e.g., In re Harris, 409 F.3d 1339, 1344 (Fed. Cir.
2005) (“Even assuming that the results were unexpected, Harris needed to
show results covering the scope of the claimed range. Alternatively Harris
needed to narrow the claims.”); In re Greenfield, 571 F.2d 1185, 1189
(CCPA 1978).
Accordingly we affirm the Examiner’s prior art rejection under 35
U.S.C. § 103 (a) for the reasons presented by the Examiner and given above.
ORDER
The Examiner’s rejection of claims 34, 36-48 and 53—55 under 35
U.S.C. § 103(a) is affirmed.
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Appeal 2016-002523
Application 13/664,399
TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1).
AFFIRMED
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